Decompensated CirrhosisPhase 1NCT05984303

Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-1b)

A Phase 1 study testing Human Umbilical Cord-derived Mesenchymal Stem Cells in people with Decompensated Cirrhosis, run by Beijing 302 Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Decompensated Cirrhosis
What is being tested?: Human Umbilical Cord-derived Mesenchymal Stem Cells
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 30 Aug 2023to 30 Aug 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing to provide written informed consent;
Aged 18 to 75 years (including 18 and 75 years), male or female;
Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and/or representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one serious complication, including esophageal and gastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications);
Child-Turcotte-Pugh (CTP) score 7 to 12 points.

Who cannot join

Hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening, or patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months.
Hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening, or patients with hepatitis C virus-related decompensated liver cirrhosis not more than 12 months on antiviral therapy.
Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.
Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.
Patients with biliary obstruction, or portal patients with vein spongiosis.

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Patients are known with other malignancies within 5 years prior to the signing of ICF, except have had curative therapy of Basal Cell Cancer, Squamous Cell Carcinoma and/or radical resection of Carcinoma in Situ.
Known to have had other malignancies within 5 years prior to signing the informed consent, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ with curable resection.
Patients with history of organ transplantation.
Patients with severe heart, lung, kidney and blood system diseases.
Patients with drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.
Patients with history of immunodeficiency disease, including a positive test result for human immunodeficiency virus (HIV) antibodies, or other acquired or congenital immunodeficiency diseases;
Pregnant or lactating female. Fertile patients who were unable or unwilling to use effective non-pharmaceutical contraception during the trial and within 6 months after the end of the trial.
Patients who had cardiovascular and cerebrovascular events (such as Unstable Angina, Brain Hemorrhage, severe Ischemic Infarction) within 3 months before the first dose；Patients who had Myocardial Infarct or a clinically significant Arrhythmia/Conduction Abnormalities within 12 months before the first dose.
Patients with hypersensitivity (allergic to more than two foods or drugs) or with a history of severe allergy, or patients with Severe allergy to a known experimental drug or to any excipient.
Patients previously received stem cell therapy or are intolerance to cell therapy;
Participants in other clinical trials within the last 3 months.
Any other clinical condition which the investigator considers would make the patient unsuitable for the trial.

Trial locations and contacts

1 site in 1 country.

Lei Shi, MD,PhD contact

86-10-66949623

shilei302@126.com

Fu-Sheng Wang, MD,PhD contact

86-10-66933332

fswang302@163.com

China1 site

Beijing 302 Hospital
Beijing
Lei Shi, MD,PhD, 86-10-66949623, shilei302@126.com

Other trials in China

About this study

Official title: Treatment of Decompensated Cirrhosis Using Human Umbilical Cord-derived Mesenchymal Stem Cells: A Phase 1, Multiple Administration, Dose-escalasion Trial (MSC-DLC-1b)

This clinical trial is a Phase 1, multiple administration, dose-escalasion clinical trial of human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis. The primary objective of this study is to assess the safety of intravenous infusion of human umbilical cord-derived mesenchymal stem cells in patients with decompensated cirrhosis.

Read the detailed description

Decompensated cirrhosis has a high overall mortality rate. There is unmet need for safe and alternative therapeutic potions. This clinical trial is a Phase 1, multiple administration, dose-escalasion clinical trial of human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis. The primary objective of this study is to assess the safety of intravenous infusion of human umbilical cord-derived mesenchymal stem cells in patients with decompensated cirrhosis.In order to illustrate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells and the patient's dose tolerance to human umbilical cord-derived mesenchymal stem cells.

Conditions: Decompensated Cirrhosis
Being tested: Human Umbilical Cord-derived Mesenchymal Stem Cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human Umbilical Cord-derived Mesenchymal Stem CellsBiological
Human Umbilical Cord-derived Mesenchymal Stem Cells will be administered intravenously.

Study groups in NCT05984303
Study group	Role	What they receive
Human Umbilical Cord-derived Mesenchymal Stem Cells	Experimental	Standard of care (SOC) plus a multiple administration and dose-escalasion with 2 cohorts with 3 subjects/cohort who receive doses of 1 and 2 ×10E8 cells. Each person received 3 infusions, 1 week apart, Proceed from lower dose to higher dose if no safety concerns for each cohort. Receives: Biological: Human Umbilical Cord-derived Mesenchymal Stem Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events
Measured: from baseline to 28th day
incidence of dose-limiting toxicity-related adverse events
Measured: from baseline to 28th day
maximum tolerated dose
Measured: from baseline to 28th day
Change in Model for End-Stage Liver Disease (MELD) score from baseline to 28th day
The Model for End-stage Liver Disease (MELD) is a scoring system that evaluates the liver function reserve and prognosis of patients with chronic liver disease by creatinine, international normalized ratio (INR), and bilirubin-conjugated cirrhosis etiology.
The MELD score is calculated by the formula: R = 9.6 × ln (creatinine mg/dl) + 3.8 × ln (bilirubin mg/dl) + 11.2 × ln (INR) + 6.4 × etiology, and the results are taken as integers. ( 0 for cholestatic and alcoholic cirrhosis and 1 for other causes of cirrhosis such as viruses).
Measured: at 28th day

Secondary outcomes (13)

Change in Model for End-Stage Liver Disease (MELD) score from baseline to 3 days, 7days, 14 days, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, and 24 months
Measured: 3 days, 7days, 14 days, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, and 24 months
Incidence of each complication associated with decompensated cirrhosis
Measured: up to 24 months
liver transplant-free survival
Measured: up to 24 months
Incidence of liver failure
Measured: up to 24 months
plasma albumin (ALB)
Measured: up to 24 months
plasma prealbumin (PALB)
Measured: up to 24 months
total bilirubin (TBIL)
Measured: up to 24 months
serum cholinesterase (CHE)
Measured: up to 24 months
prothrombin time (PT)
Prothrombin time (PT) is a blood test that measures the time it takes for plasma to clot, to check for bleeding problems, or to check whether medicine to prevent blood clots is working.
Measured: up to 24 months
Child-Turcotte-Pugh (CTP) score
Child-Turcotte-Pugh (CTP) score is a scoring system that evaluates the liver function.
Maximum is 15, minimum is 5. Higher scores mean a worse outcome.
Measured: up to 24 months
EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D)
Quality of life assessment. Maximum is 5, minimum is 1. Lower scores mean a better outcome.
Measured: up to 24 months
Incidence of liver cancer
Measured: up to 24 months
ChronicLiver Disease Questionnaire (CLDQ)
Quality of life assessment. The Chronic Liver Disease Questionnaire (CLDQ) was developed as an evaluative instrument to measure longitudinal change in health status within individuals with chronic liver disease. In addition to measuring both physical and mental health, the instrument was designed to be a disease-specific tool for assessing areas of function important to patients with chronic liver disease. Maximum is 7, minimum is 1. Higher scores mean a better outcome.
Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202330 Aug 2025

First posted9 Aug 2023
Study start30 Aug 2023 (estimated)
Primary completion30 Aug 2024 (estimated)
Study completion30 Aug 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05984303
Sponsor's protocol ID: MSC-DLC-1b
Status last verified: Aug 2023
First submitted: 28 Jul 2023
Last updated: 9 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed.

Publications

Shi L, Zhang Z, Mei S, Wang Z, Xu Z, Yao W, Liu L, Yuan M, Pan Y, Zhu K, Liu K, Meng F, Sun J, Liu W, Xie X, Dong T, Huang L, Meng F, Fu JL, Li Y, Zhang C, Fan X, Shi M, Zhang Y, Li Y, Xie WF, Zhang P, Wang FS. Dose-escalation studies of mesenchymal stromal cell therapy for decompensated liver cirrhosis: phase Ia/Ib results and immune modulation insights. Signal Transduct Target Ther. 2025 Jul 29;10(1):238. doi: 10.1038/s41392-025-02318-4.
PubMed 40721581

Want to know more?

Lei Shi, MD,PhD

86-10-66949623

shilei302@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 4
Low Dose Versus Standard Dose Albumin
Decompensated Cirrhosis and Ascites
Not yet recruitingObservational study
Risk Stratification for Adverse Events in End-Stage Liver Disease
Decompensated Cirrhosis
RecruitingObservational study
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Ascites, Variceal Bleeding
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Recruiting
Hospital @ Home Model of Care for Cirrhosis
Decompensated Cirrhosis

All Decompensated Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Decompensated Cirrhosis Using Human Umbilical Cord-derived Mesenchymal Stem Cells: A Phase 1, Multiple Administration, Dose-escalasion Trial (MSC-DLC-1b)
ClinicalTrials.gov ID: NCT05984303
Acronym / sponsor ID: MSC-DLC-1b
Conditions: Decompensated Cirrhosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 6 participants (estimated)
Lead sponsor: Beijing 302 HospitalUniversity, hospital or other
Collaborators: Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
Study start: 30 Aug 2023 (estimated)
Primary completion: 30 Aug 2024 (estimated)
Study completion: 30 Aug 2025 (estimated)
First posted: 9 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Human Umbilical Cord-derived Mesenchymal Stem Cells	Experimental	Biological: Human Umbilical Cord-derived Mesenchymal Stem CellsStandard of care (SOC) plus a multiple administration and dose-escalasion with 2 cohorts with 3 subjects/cohort who receive doses of 1 and 2 ×10E8 cells. Each person received 3 infusions, 1 week apart, Proceed from lower dose to higher dose if no safety concerns for each cohort.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Willing to provide written informed consent;
Aged 18 to 75 years (including 18 and 75 years), male or female;
Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and/or representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one serious complication, including esophageal and gastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications);
Child-Turcotte-Pugh (CTP) score 7 to 12 points.

Key exclusion criteria (18 listed)

Hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening, or patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months.
Hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening, or patients with hepatitis C virus-related decompensated liver cirrhosis not more than 12 months on antiviral therapy.
Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.
Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Human Umbilical Cord-derived Mesenchymal Stem CellsHuman Umbilical Cord-derived Mesenchymal Stem Cells will be administered intravenously.	Biological	Human Umbilical Cord-derived Mesenchymal Stem Cells

Primary outcome

Incidence of Adverse Events
Time frame: from baseline to 28th day
incidence of dose-limiting toxicity-related adverse events
Time frame: from baseline to 28th day
maximum tolerated dose
Time frame: from baseline to 28th day
Change in Model for End-Stage Liver Disease (MELD) score from baseline to 28th day
Time frame: at 28th day
The Model for End-stage Liver Disease (MELD) is a scoring system that evaluates the liver function reserve and prognosis of patients with chronic liver disease by creatinine, international normalized ratio (INR), and bilirubin-conjugated cirrhosis etiology. The MELD score is calculated by the formula: R = 9.6 × ln (creatinine mg/dl) + 3.8 × ln (bilirubin mg/dl) + 11.2 × ln (INR) + 6.4 × etiology, and the results are taken as integers. ( 0 for cholestatic and alcoholic cirrhosis and 1 for other causes of cirrhosis such as viruses).

13 secondary outcomes

Change in Model for End-Stage Liver Disease (MELD) score from baseline to 3 days, 7days, 14 days, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, and 24 months
Time frame: 3 days, 7days, 14 days, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, and 24 months
Incidence of each complication associated with decompensated cirrhosis
Time frame: up to 24 months
liver transplant-free survival
Time frame: up to 24 months
Incidence of liver failure
Time frame: up to 24 months
plasma albumin (ALB)
Time frame: up to 24 months
plasma prealbumin (PALB)
Time frame: up to 24 months
total bilirubin (TBIL)
Time frame: up to 24 months
serum cholinesterase (CHE)
Time frame: up to 24 months
prothrombin time (PT)
Time frame: up to 24 months
Child-Turcotte-Pugh (CTP) score
Time frame: up to 24 months
EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D)
Time frame: up to 24 months
Incidence of liver cancer
Time frame: up to 24 months
ChronicLiver Disease Questionnaire (CLDQ)
Time frame: up to 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
Derived from this study: PubMed 40721581Shi L, Zhang Z, Mei S, Wang Z, Xu Z, Yao W, Liu L, Yuan M, Pan Y, Zhu K, Liu K, Meng F, Sun J, Liu W, Xie X, Dong T, Huang L, Meng F, Fu JL, Li Y, Zhang C, Fan X, Shi M, Zhang Y, Li Y, Xie WF, Zhang P, Wang FS. Dose-escalation studies of mesenchymal stromal cell therapy for decompensated liver cirrhosis: phase Ia/Ib results and immune modulation insights. Signal Transduct Target Ther. 2025 Jul 29;10(1):238. doi: 10.1038/s41392-025-02318-4.
Individual participant dataSharing planned: Yes. After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed.

Related trials for Decompensated Cirrhosis

Enrolling by invitationPhase 4
Low Dose Versus Standard Dose Albumin
Decompensated Cirrhosis and Ascites
Not yet recruitingObservational study
Risk Stratification for Adverse Events in End-Stage Liver Disease
Decompensated Cirrhosis
RecruitingObservational study
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Ascites, Variceal Bleeding
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Recruiting
Hospital @ Home Model of Care for Cirrhosis
Decompensated Cirrhosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lei Shi, MD,PhD contact

86-10-66949623

shilei302@126.com

Fu-Sheng Wang, MD,PhD contact

86-10-66933332

fswang302@163.com

Fu-Sheng Wang, MD, PhD study chair

Beijing 302 Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Human Umbilical Cord-derived Mesenchymal Stem Cells in people with Decompensated Cirrhosis, run by Beijing 302 Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lei Shi, MD,PhD (86-10-66949623, shilei302@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: from baseline to 28th day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05984303, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.